Tope et al

Title: Comparison of topical methyl aminolevulinate photodynamic therapy versus placebo photodynamic therapy in nodular BCC.

Author: Tope WD, Menter A, El-Azhary RA, Lowe NJ, Jarratt MT, Rich P, et al.

Journal Reference: J Eur Acad Dermatol Venereol 2004;18(Suppl 2):413-4.

Objective: to assess the efficacy, safety and cosmetic outcome of photodynamic therapy using methyl aminolevulinate (MAL; Metvix®) or placebo in the treatment of nodular basal cell carcinoma.

Design: this was a multicentre, randomised, double-blind placebo-controlled trial. A total of 65 adult patients, with histologically proven, nodular basal cell carcinoma were randomised to receive photodynamic treatment (PDT) with either MAL (33 patients) or placebo cream (32 patients). Lesions were prepared by surface debridement (up to four times) before the cream was applied.

Lesions showing partial clinical response at three-months were re-treated; those showing no response were surgically excised. At six-months after last treatment, lesions showing complete clinical response were excised for histological examination.
Assessments of treatment efficacy were made at three- and six-months after last treatment.

Key Results:

  • Complete clinical response with MAL-PDT was significantly superior (P<0.001) compared with placebo.
  • At 6-months post-treatment, the overall lesion clinical response was 80% with MAL and 51% for the placebo cream.
  • The overall complete histological response was 78% in the active group, compared with 33% for the placebo.
  • Of the 45 lesions in the MAL-PDT group, 32 were assessed as clinically cured, with 87.5% showing no sign of malignancy on histological examination.
  • Investigators judged cosmetic outcome as good or excellent in 93% of sites with a complete clinical response in the active treatment group, compared with 90% of the placebo-PDT sites. 
  • Most patients (60%) thought that MAL-PDT was better than treatments received previously.
  • Only local adverse events were reported by both groups. Most reactions were considered mild or moderate. Median duration of pain was shorter in the active treatment group (2 days) than with placebo (3-6 days).

Conclusion: Photodynamic therapy with methyl aminolevulinate cream (MAL; Metvix®) is significantly superior to that with placebo in the treatment of nodular basal cell carcinomas. It is well tolerated and gives excellent cosmetic results.